Sinus health company SinuSys Corporation, has announced that it has received CE Mark for its AerOs™ Sinus Dilation System. AerOs is designed to gently open the sinus ostia, thereby restoring natural sinus drainage and ventilation using a simple, two-step interventional approach.

Background

Chronic sinusitis affects more than 31 million people in the United States which makes it more prevalent than heart disease and asthma. SinuSys Corporation claims, as it would, that the condition has a greater impact on patients’ quality of life than chronic back pain or congestive heart failure.

Despite the fact that the U.S. healthcare system currently spends more than $8 billion annually on improving the health of patients with sinus conditions, approximately 20 percent of sinusitis patients reportedly do not experience adequate relief from current pharmaceutical treatments, which can have unpleasant side effects even when effective. For these patients, the most effective treatments to date have been Functional Endoscopic Sinus Surgery (FESS) and high-pressure balloon dilation, which can cause significant patient discomfort and are conducted in a surgical suite under general anesthesia or IV sedation.

Unlike balloon dilation devices that use rapid, high-pressure inflation, the AerOs Sinus Dilation System is a low pressure, self-expanding insert which is designed to gently and gradually open the maxillary ostia. The AerOs device incorporates the Company’s proprietary osmotic technology, which utilises the body’s natural fluids to expand the insert. After the ostia are opened, the insert is removed. The low-pressure, gradual expansion and simplicity of the device are designed to make it compatible for use in office-based procedures under local anaesthesia.

Clinician comments

“In our current clinical study of patients treated in the operating room, the AerOs System is demonstrating the attributes that may make it a tool of choice to treat chronic sinusitis in an office setting. The device is simple to use and its low-pressure expansion should be well-tolerated by patients under local anesthesia,” said Dr. Amin Javer, Director of the University of British Columbia Sinus Centre. “Ultimately, this may allow us to treat sinus disease earlier in its progression to help a broader range of patients.”

Company comments

“Our CE Mark demonstrates the significant momentum we are generating leading toward a global presence,” said SinuSys Chief Executive Officer Thomas Schreck. “We are enthusiastic about commercialisation of the AerOs System for otolaryngologists and their sinusitis patients in Europe. At the same time, we plan to expand application of our technology into other devices that can address the multi-factorial nature of sinus disease, including devices for the frontal and sphenoid sinuses.”

Regulatory status

The Company has shipped devices to the United Kingdom in the first phase of its European commercialisation strategy, while it completes its initial clinical study in Canada and awaits a response to its FDA 510(k) submission.